Opioid overdoses involving xylazine in emergency department patients: a multicenter study.

INTRODUCTION: Illicit opioids, consisting largely of fentanyl, novel synthetic opioids, and adulterants, are the primary cause of drug overdose fatality in the United States. Xylazine, an alpha-2 adrenergic agonist and veterinary tranquilizer, is being increasingly detected among decedents following illicit opioid overdose. Clinical outcomes in non-fatal overdose involving xylazine are unexplored. Therefore, among emergency department patients with illicit opioid overdose, we evaluated clinical outcome differences for patients with and without xylazine exposures. METHODS: This multicenter, prospective cohort study enrolled adult patients with opioid overdose who presented to one of nine United States emergency departments between 21 September 2020, and 17 August 2021. Patients with opioid overdose were screened and included if they tested positive for an illicit opioid (heroin, fentanyl, fentanyl analog, or novel synthetic opioid) or xylazine. Patient serum was analyzed via liquid chromatography quadrupole time-of-flight mass spectroscopy to detect current illicit opioids, novel synthetic opioids, xylazine and adulterants. Overdose severity surrogate outcomes were: (a) cardiac arrest requiring cardiopulmonary resuscitation (primary); and (b) coma within 4 h of arrival (secondary). RESULTS: Three hundred and twenty-one patients met inclusion criteria: 90 tested positive for xylazine and 231 were negative. The primary outcome occurred in 37 patients, and the secondary outcome occurred in 111 patients. Using multivariable regression analysis, patients positive for xylazine had significantly lower adjusted odds of cardiac arrest (adjusted OR 0.30, 95% CI 0.10-0.92) and coma (adjusted OR 0.52, 95% CI 0.29-0.94). CONCLUSIONS: In this large multicenter cohort, cardiac arrest and coma in emergency department patients with illicit opioid overdose were significantly less severe in those testing positive for xylazine.

A Multicenter Investigation of Factors Influencing Women's Participation in Clinical Trials.

OBJECTIVE: To identify factors that influence women's participation in clinical research. METHODS: We administered a survey in outpatient and inpatient populations of Obstetrics and Gynecology facilities of six institutions located in four states. The survey included questions regarding any of the participant's past experiences in clinical research and the factors that would influence their participation in clinical research. Analyses included descriptive statistics and a Principal Component Analysis. RESULTS: The analysis included 3,773 respondents; 2,477 (68.1%) were pregnant. The majority of participants were Caucasian (1,453, 40.2%), followed by Hispanic (933, 25.8%), African American/black (744, 20.6%), other minorities (270, 7.5%), and multiracial (212, 5.9%). Ten potential motivating factors and 10 potential barriers were assessed. The greatest motivating factor was "how well research is explained" (mean = 2.87) while "risk of unknown side effects" was the greatest barrier (mean = 3.07) for women's participation in clinical trials. Among six helpful resources assessed, "material in my own language" was scored as the highest (mean = 2.8) in facilitating women's decision to participate. For "risk to the fetus/future fertility" as a barrier, pregnant women's score (mean = 3.25) was significantly higher than nonpregnant women's score (mean = 2.37). CONCLUSIONS: Overall, the risk of unknown side effects discourages women in general, and the risk to the fetus/future fertility discourages pregnant women the most from participating in clinical trials. However, explaining a study well and providing written material in the patients' own language may increase their willingness to participate.

Impact of Race Versus Education and Race Versus Income on Patients' Motivation to Participate in Clinical Trials.

Our study investigates whether levels of motivation and barriers to participation in clinical trials vary with patients' education and income. A self-administered survey asked outpatients to rank potential influential factors on a "0" to "4" significance scale for their motivation to participate in clinical trials. Principal component analysis (PCA), analysis of variance (ANOVA), Kruskal-Wallis, and Mann-Whitney U tests analyzed the impact of race, education, and income on their motivation to participate. Analysis included 1841 surveys; most respondents had a high school education or some college, and listed annual income < $30,000. There was a significant interaction between race and income on our motivation scale 1 scores (p = .0261). Compared with their counterparts, subjects with less education/lower income ranked monetary compensation (p = .0420 and p < .0001, respectively) as a higher motivator. Minorities and patients with less education and lower income appear to be more influenced by their desire to please the doctor, the race and sex of the doctor, and the language spoken by the doctor being the same as theirs. For all races, education appeared to have a direct relationship with motivation to participate, except for African-Americans, whose motivation appeared to decline with more education. Income appeared to have an inverse relationship with motivation to participate for all races.

Factors Influencing Participation in Clinical Trials: Emergency Medicine vs. Other Specialties.

INTRODUCTION: This study investigated factors that influence emergency medicine (EM) patients' decisions to participate in clinical trials and whether the impact of these factors differs from those of other medical specialties. METHODS: A survey was distributed in EM, family medicine (FM), infectious disease (ID), and obstetrics/gynecology (OB/GYN) outpatient waiting areas. Eligibility criteria included those who were 18 years of age or older, active patients on the day of the survey, and able to complete the survey without assistance. We used the Kruskal-Wallis test and ordinal logistic regression analyses to identify differences in participants' responses. RESULTS: A total of 2,893 eligible subjects were approached, and we included 1,841 surveys in the final analysis. Statistically significant differences (p≤0.009) were found for eight of the ten motivating factors between EM and one or more of the other specialties. Regardless of a patient's gender, race, and education, the relationship with their doctor was more motivating to patients seen in other specialties than to EM patients (FM [odds ratio {OR}:1.752, 95% confidence interval {CI}{1.285-2.389}], ID [OR:3.281, 95% CI{2.293-4.695}], and OB/GYN [OR:2.408, 95% CI{1.741-3.330}]). EM's rankings of "how well the research was explained" and whether "the knowledge learned would benefit others" as their top two motivating factors were similar across other specialties. All nine barriers showed statistically significant differences (p≤0.008) between EM and one or more other specialties. Participants from all specialties indicated "risk of unknown side effects" as their strongest barrier. Regardless of the patients' race, "time commitment" was considered to be more of a barrier to other specialties when compared to EM (FM [OR:1.613, 95% CI{1.218-2.136}], ID [OR:1.340, 95% CI{1.006-1.784}], or OB/GYN [OR:1.901, 95% CI{1.431-2.526}]). Among the six resources assessed that help patients decide whether to participate in a clinical trial, only one scored statistically significantly different for EM (p<0.001). EM patients ranked "having all material provided in my own language" as the most helpful resource. CONCLUSION: There are significant differences between EM patients and those of other specialties in the factors that influence their participation in clinical trials. Providing material in the patient's own language, explaining the study well, and elucidating how their participation might benefit others in the future may help to improve enrollment in EM-based clinical trials.

Research Professionals' Perspectives, Barriers, and Recommendations Regarding Minority Participation in Clinical Trials.

OBJECTIVE: This study aims to investigate research professionals' perspectives regarding minority participation in clinical trials. METHODS: A web-based survey of research professionals at US institutions receiving NIH and/or AHRQ funding to conduct clinical research in 2013. Descriptive statistics, mean, standard deviation (SD), and the Wilcoxon rank-sum test were utilized for analysis. RESULTS: Distributed were 13,041 surveys with 967 (7.4%) responses. Overall and race-stratified analyses included 633 and 521 surveys, respectively. A majority agreed that patients' race (mean, 3.4; SD = 1.0) and primary language (mean, 4.0; SD = 0.9) have an effect on enrollment. They had more success in enrolling those whose primary language was the same as their own (mean, 3.8; SD = 1.0), and that a language barrier and time spent arranging for interpreters had prevented them from offering a study to potential candidates (mean, 3.2; SD = 1.2). Non-Caucasian respondents were more likely to agree that "fear of unknown side effects" was a deterrent for minorities (p < 0.01), "minorities are more likely to be unavailable for follow-up phone calls" (p = 0.07), and "the unavailability of translated material discourages non-English speakers from participation" (p = 0.08). They also were more likely to be neutral or agree with being discouraged from enrolling minorities because of the possibility of their withdrawal or being less likely to be available for phone follow-ups and follow-up visits (all p < 0.01). CONCLUSION: Despite a few subtle racial differences in research professionals' perspectives, a majority expressed no hesitation in enrolling minorities. Patients' race and primary language appeared to influence enrollment. A language barrier appeared to be the strongest barrier for research professionals.

Racial Differences Among Factors Associated with Participation in Clinical Research Trials.

OBJECTIVE: To identify whether racial differences exist among various factors associated with patients' decision to participate in clinical research trials. METHODS: A self-administered, IRB-approved survey was utilized with inclusion criteria requiring subjects to be 18 years of age or older, having active patient status and ability to complete the survey without assistance. Subjects were asked to rate potential influential motivators, barriers, and facilitators on a "no influence" (0) to "most influence" (4) scale for participation in research that tests a new drug or device. Kruskal-Wallis testing was used to identify factors significantly associated with race. RESULTS: Analysis included 1643 surveys: 949 (57.8 %) Caucasian; 217 (13.2 %) African-American; 317 (19.3 %) Hispanic; 62 (3.8 %) Multiracial; and 98 (6.0 %) "Other" minorities. Statistically significant differences (p ≤ .02) by race were found for five out of ten motivating factors. "How well the research study is explained to me" had the highest mean value for all races except other minorities, for whom "Knowledge learned from my participation will benefit someone in the future" scored highest. "Risk of unknown side-effects" was the greatest barrier for all races. CONCLUSION: Racial differences exist not only between Caucasians and Minorities for the factors associated with their clinical trial participation, but also among different minority races themselves. To promote diversity in research, recruitment strategies for each individual race should be customized based on what matters to the target population.

Perceived Fall Risk and Functional Decline: Gender Differences in Patient's Willingness to Discuss Fall Risk, Fall History, or to Have a Home Safety Evaluation.

The CDC reports that among older adults, falls are the leading cause of injury-related death and rates of fall-related fractures among older women are twice those of men. We set out to 1) determine patient perceptions (analyzed by gender) about their perceived fall risk compared to their actual risk for functional decline and death and 2) to report their comfort level in discussing their fall history or a home safety plan with their provider. Elders who presented to the Emergency Department (ED†) were surveyed. The survey included demographics, the Falls Efficacy Scale (FES) and the Vulnerable Elders Survey (VES); both validated surveys measuring fall concern and functional decline. Females had higher FES scores (mean 12.3, SD 5.9) than males (mean 9.7, SD 5.9 p = .007) in the 146 surveys analyzed. Females were more likely to report an increased fear of falling, and almost three times more likely to have a VES score of 3 or greater than males (OR = 2.86, 95% CI: 1.17-7.00, p = .02). A strong correlation was observed between FES and VES scores (r = 0.80, p < .001). No difference in correlation was observed between males and females, p = .26. Participants (77 percent) reported they would be comfortable discussing their fall risk with a provider; there was no difference between genders (p = .57). In this study, irrespective of gender, there appears to be a high association between subjects' perceived fall risk and risk for functional decline and death. The majority of patients are likely willing to discuss their fall risk with their provider. These findings may suggest a meaningful opportunity for fall risk mitigation in this setting.

Characteristics of participants in peripartum interventional research.

OBJECTIVE: To identify characteristics of pregnant women potentially influencing the decision to participate in peripartum interventional research. METHODS: Women screened as eligible to participate in two prospective interventional trials conducted in the labor and delivery unit at a single center were included. Characteristics of eligible women were compared based on their decision whether to participate or not. The best predictors of research participation were identified using multivariable logistic regression analyses. RESULTS: Of the 605 subjects who screened as eligible to participate, 363 (60%) agreed to participate and 242 (40%) declined. Women using a private obstetric provider or who had prior obstetrical complications were less likely to participate [aOR 0.6 (95% CI: 0.4-0.8)] and [aOR 0.6 (95% CI: 0.4-0.9)], respectively. A history of a mental health condition and a higher body mass index (BMI) were marginally more likely to participate [aOR 1.5 (95% CI: 1.0-2.3)] and [aOR 1.03 (95% CI: 1.0-1.1)], respectively. Overall logistic regression model R(2) was 0.23. CONCLUSIONS: There are differences between eligible subjects who decide to participate or not participate in prospective peripartum interventional research. There is a need to better understand non-participation in order to improve recruitment of representative populations that allow more generalizable research results.

Mechanical falls: are patients willing to discuss their risk with a health care provider?

BACKGROUND: Falls in the elderly cause serious injury. OBJECTIVE: We aimed to determine subjects' comfort in discussing fall risk and home safety evaluations. METHODS: This prospective study surveyed a convenience sample of subjects (≥50 years old) in an emergency department (ED), health fair (HF), and family practice (FP). The survey included the Falls Efficacy Scale and Vulnerable Elders Survey-validated surveys measuring fall concern and functional decline. Other data-environmental living conditions, participant behaviors, fall frequency-were collected. The associations between perceived fall risk and participant characteristics were assessed using descriptive statistics and random-effects logistic regression. RESULTS: Participants (n = 416, 38% males, 62% females) had a mean age of 67.6 years; 35% were high fall risk. Previous year falls (p = 0.002), use of assistive device (p < 0.001), having at least one alcoholic drink/week (p = 0.043), and poor or fair perceived health status (p < 0.001) were associated with perceived fall risk. HF respondents were more willing than FP respondents to discuss falls (84.9% vs. 73.1%, p = 0.025). The difference was not significant between the HF and ED respondents (84.9% vs. 76.9, p = 0.11). HF subjects were more willing than FP to have a home safety inspection (68.9% vs. 45.9%, p < 0.001). The difference was not significant between the HF and ED respondents (68.9% vs 58.5, p = 0.09). CONCLUSIONS: Perceived and actual fall risks are highly associated. Most participants are willing to discuss their fall risk and a home safety evaluation. HF subjects were most willing to have these discussions; ED subjects were less willing than HF, but not significantly different from health fair participants. FP participants were significantly less willing to have these discussions than HF participants. This may suggest a meaningful opportunity for fall risk prevention in outpatient settings such as health fairs and the ED.

Effect of triage-based use of the Ottawa foot and ankle rules on the number of orders for radiographic imaging.

CONTEXT: Reducing unnecessary testing lessens the cost burden of medical care, but decreasing use depends on consistently following evidence-based clinical decision rules. The Ottawa foot and ankle rules (OFARs) are validated, longstanding evidence-based guidelines to predict fractures. Frequently, radiography is automatically ordered for acute ankle injuries despite findings from OFARs suggesting no fracture. OBJECTIVES: First, to determine whether implementation of protocol-driven use of the OFARs at triage would decrease the number of radiography orders and length of stay (LOS) in the emergency department. Second, to quantify the incidence of OFARs use at triage and to assess patient expectations of radiography use and patient satisfaction as rated by both patients and clinicians. METHODS: In this prospective, 2-stage sequential pilot study, patients with acute ankle and foot injuries were screened in the emergency department between January 2013 and October 2013. In the first stage, clinicians (physician assistants, residents, and attending physicians) performed their usual practice habits for radiography use in the control group. For the second stage, they were educated to appropriately apply the OFARs before ordering radiography. For patients who were suspected of having a fracture at triage, nursing staff ordered radiography. For patients who were not suspected of having a fracture at triage, a clinician reassessed them using the OFARs after their triage assessment. Radiography was then ordered at the discretion of the clinician. Results gathered after training in the OFARs comprised the intervention group. After discharge, patients were surveyed regarding their expectations and satisfaction, and clinicians were surveyed on their perceptions of patient satisfaction. RESULTS: A total of 131 patients were screened, 62 patients were enrolled in the study after consent was obtained, and 2 patients withdrew from the study prematurely, leaving 30 patients in each group. Fifty-eight of the 60 patients (97%) underwent radiography. Emergency department LOS decreased from 103 minutes to 96.5 minutes (P=.297) after the OFARs were applied. There was also a decrease in LOS in patients with a fracture (137 minutes vs 103 minutes [P=.112]). Radiography was expected to be ordered by 27 of 30 patients in the control group (90%) and 24 of 30 in the intervention group (80%) (P=.472). Patients were equally satisfied among the groups (54 of 60 [90%]) (with no difference between groups), and 27 of 30 (90%) vs 30 of 30 (100%) clinicians in the control and intervention groups, respectively, perceived that patients were satisfied with their treatment. CONCLUSION: There was no statistical evidence that application of the OFARs decreases the number of imaging orders or decreases LOS. This observation suggests that even when clinicians are being observed and instructed to use clinical decision rules, their evaluation bias tends toward recommendations for testing.

Sex differences in cardiac arrest survivors who receive therapeutic hypothermia.

OBJECTIVE: Sex differences have not been well defined for patients undergoing therapeutic hypothermia (TH). We aimed to determine sex differences in mortality and Cerebral Performance Category (CPC) scores at discharge among those receiving TH. METHODS: This retrospective cohort study used data abstracted from an "ICE alert" database, an institutional protocol expediting mild TH for postarrest patients. Quality assurance variables (such as age, time to TH, CPC scores, and mortality) were reviewed and compared by sex. χ2 Test and Wilcoxon rank sum test were used. Stepwise logistic regression was used to assess the association between mortality and sex, while controlling for patient characteristics and clinical presentation of cardiac arrest. RESULTS: Three hundred thirty subjects were analyzed, 198 males and 132 females. Subjects' mean age (SD) was 61.7 years (15.0); there was no significant sex difference in age. There were no statistically significant sex differences in history of coronary artery disease, congestive heart failure, arrhythmia, hypertension, chronic obstructive pulmonary disease, renal disease, type 1 and/or type 2 diabetes mellitus, or those previously healthy. Obesity (body mass index>35 kg/m2) was more likely in females (37, 28.0%) than males (35, 17.7%); P=.03. Females (64, 49.6%) were more likely than males (71, 36.8%) to have shock; P=.02. There was no difference in arrest to initiating hypothermia, but there was a significant difference in time to target temperature (in median minutes, interquartile range): male (440, 270) vs female (310, 270), P=.003. There was no statistical difference in CPC at discharge. Crude mortality was not different between sexes: male, 67.7%; female, 70.5%; P=.594. However, after controlling for differences in age, obesity, shock, and other variables, females were less likely to die (odds ratio, 0.46; 95% confidence interval, 0.23-0.92; P=.03) than males. CONCLUSION: There is no statistically significant difference in CPC or crude mortality outcomes between sexes. After adjusting for confounders, females were 54% less likely to die than males.

Comparison of 12-hour urine protein and protein:creatinine ratio with 24-hour urine protein for the diagnosis of preeclampsia.

OBJECTIVE: The purpose of this study was to evaluate the performance of the 12-hour urine protein >165 mg and protein:creatinine ratio >0.15 for the prediction of 24-hour urine protein of ≥300 mg in patients with suspected preeclampsia. STUDY DESIGN: We performed a prospective observational study of 90 women who had been admitted with suspected preeclampsia. Protein:creatinine ratio and 12- and 24-hour urine specimens were collected for each patient. Test characteristics for the identification of 24-hour urine protein ≥300 mg were calculated. RESULTS: A 12-hour urine protein >165 mg and protein:creatinine ratio of >0.15 correlated significantly with 24-hour urine protein ≥300 mg (r = 0.99; P < .001; and r = 0.54; P < .001, respectively). A 12-hour urine protein >165 mg performed better than protein:creatinine ratio as a predictor of a 24-hour urine protein ≥300 mg (sensitivity, 96% and 89%; specificity, 100% and 49%; positive predictive value, 100% and 32%; negative predictive value, 98% and 91%, respectively). CONCLUSION: The high correlation of a 12-hour urine protein >165 mg with a 24-hour urine protein ≥300 mg (with the benefit of a shorter evaluation time) and the high negative predictive value of protein:creatinine ratio suggest that the use of both these tests have a role in the evaluation and treatment of women with suspected preeclampsia.